The Effect of Virtual Reality Therapy on Balance and Knee Control in Stroke Patients

March 30, 2024 updated by: Suleyman Korkusuz, Hacettepe University

The Effect of Virtual Reality Therapy Applied in Addition to Conventional Balance Training on Balance and Knee Control in Stroke Patients

The aim of study is to determine whether the Virtual Reality training applied in addition to the exercises given inside and outside the parallel bar is effective on balance, daily living activities and knee control in stroke patients.

The hypotheses of the study are:

Hypothesis 1:

H0: Virtual reality training has no effect on balance in stroke patients. H1: Virtual reality training has an effect on balance in stroke patients.

Hypothesis 2; H0: Virtual reality training has no effect on activities of daily living in stroke patients.

H1: Virtual reality training has an effect on daily living activities in stroke patients.

Hypothesis 3; H0: Virtual reality training has no effect on knee control in stroke patients. H1: Virtual reality training has an effect on knee control in stroke patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In recent years, virtual reality systems are widely preferred technology-assisted rehabilitation methods due to the many advantages they provide in stroke rehabilitation. Virtual reality increases the quality of movement and functional capacity both by providing a sensory environment and by motor learning.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Ankara, Turkey
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-70
  • Having a stroke for the first time
  • Patients who can stand and walk independently

Exclusion Criteria:

  • Having neglect syndrome
  • Being bilaterally affected
  • Botulinum toxin application in the last three months
  • Having additional neurological diseases such as Parkinson's, multiple sclerosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional Rehabilitation Group
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Other: Conventional Rehabilitation
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Experimental: Virtual Reality Therapy Group
The patients in this group will be able to play balance-based games with the Virtual Reality System for 20 minutes, 3 days a week, together with the conventional rehabilitation program.
Other: Conventional Rehabilitation
In the conventional rehabilitation program, bed exercises, mat activities, balance exercises inside or outside the parallel bar and walking training will be given to the patients every weekday.
Other: Virtual Reality Therapy
Patients in this group will play balance-based games with the Virtual Reality System.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Computerized Gait Assessment System (Zebris Rehawalk)
Time Frame: Baseline
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
Baseline
Computerized Gait Assessment System (Zebris Rehawalk)
Time Frame: 6.week (at the end of the training)
Participants will walk at a comfortable walking speed on the treadmill. During the walk, the walk will be recorded with the video camera system integrated into the device. With the help of the system, the knee hyperextension angle during walking will be calculated with the markers placed on the recorded video.
6.week (at the end of the training)
Barthel Index
Time Frame: Baseline
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
Baseline
Barthel Index
Time Frame: 6.week (at the end of the training)
This scale consists of 10 items that evaluate nutrition, bathing, self-care, dressing, defecation control, urine control, going to the toilet, ability to move from bed to wheelchair, mobility status such as walking or being dependent on a wheelchair, and stair climbing functions.
6.week (at the end of the training)
Functional Reach Test
Time Frame: Baseline
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
Baseline
Functional Reach Test
Time Frame: 6.week (at the end of the training)
It is based on the principle of lifting the arm 90° upwards and reaching forward as far as possible while keeping the feet on the ground. 15 cm. and the risk of falling below 15 cm increases significantly, between 15 and 25 cm. indicates a moderate risk of falling. Values less than 25.4 cm indicate an increased risk of falling.
6.week (at the end of the training)
Timed Up and Go Test
Time Frame: Baseline
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
Baseline
Timed Up and Go Test
Time Frame: 6.week (at the end of the training)
It is an objective, reliable and simple measure for assessing balance and functional mobility. It can also be used for assessment of fall risk.
6.week (at the end of the training)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Büşra Seçkinoğulları, MSc, Hacettepe University
  • Study Chair: Özlem Yürük, Prof.Dr., Baskent University
  • Principal Investigator: Süleyman Korkusuz, MSc, Atılım University
  • Study Chair: Gülşen Taşkın, Assist.Prof, Afyonkarahisar Sağlık Bilimleri University
  • Study Chair: Melike Sümeyye Cengiz, MSc, Bandırma Onyedi Eylül University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-77

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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